RESCUE BT 2, a multicenter, randomized, double-blind, double-dummy trial of intravenous tirofiban in acute ischemic stroke: Study rationale and design.

Abstract

BACKGROUND:

Tirofiban is a glycoprotein IIb/IIIa receptor inhibitor that has been shown to be effective in the treatment of acute coronary syndromes. However, it remains unknown whether it improves outcomes in patients with acute ischemic stroke.

OBJECTIVE:

This trial investigates the efficacy and safety of tirofiban compared with aspirin for acute ischemic stroke within 24 h after symptom onset.

METHODS AND DESIGN:

The Efficacy and Safety of Tirofiban Compared with Aspirin in the Treatment of Acute Ischemic Stroke (RESCUE BT 2) Trial is an investigator-initiated, prospective, randomized, double-blind, double-dummy, multicenter clinical trial. Up to 1158 eligible patients will be consecutively randomized to receive antiplatelet therapy with tirofiban or aspirin in 1:1 ratio across approximately 100 stroke centers in China.

OUTCOMES:

The primary endpoint is the proportion of patients with excellent functional outcomes defined as a modified Rankin scale score of 0 to 1 at 90 days after randomization. Lead safety endpoints include mortality at 90 days and symptomatic intracerebral hemorrhage within 48 h after treatment.

TRIAL REGISTRY NUMBER:

ChiCTR2000029502 (www.chictr.org.cn).

• Authors: Wenjie Zi, Jiaxing Song, Zhongming Qiu, Weilin Kong, Jiacheng Huang, Weidong Luo, Shuai Liu, Hongfei Sang, Jie Yang, Linyu Li, Yan Tian, Jinrong Hu, Jeffrey L Saver, Raul G Nogueira, Fengli Li, Qingwu Yang
• Journal: International journal of stroke : official journal of the International Stroke Society (Int J Stroke) Vol. 18 Issue 5 Pg. 620-625 (06 2023) ISSN: 1747-4949 [Electronic] United States
• PMID: 35993176 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Tirofiban
• Platelet Aggregation Inhibitors
• Tyrosine
• Aspirin

Topics

• Humans
• Tirofiban (therapeutic use)
• Platelet Aggregation Inhibitors (adverse effects)
• Stroke
• Ischemic Stroke (drug therapy)
• Prospective Studies
• Tyrosine (therapeutic use)
• Aspirin (therapeutic use)
• Double-Blind Method
• Treatment Outcome